From Startup Brainstorm Cell Therapeutics
Link to Full Article: http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=irol-newsArticle&ID=2379449
Poster highlights enrichment strategies for clinical trials in ALS
NEW YORK, Dec. 04, 2018 (GLOBE NEWSWIRE) — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases, announced today that a poster presentation highlighting a comprehensive review of ALS clinical trial enrichment strategies will be presented at the 29th International Symposium on ALS/MND. The symposium will take place December 7 – 9, 2018 at the Scottish Events Campus Centre in Glasgow, Scotland.
Dr. Namita Goyal, Associate Clinical Professor and Director of the ALS Clinic for the Department of Neurology at UCI Health will present a poster titled, “A Systematic Review of Enrichment Strategies for Current Clinical Trials in ALS,” on December 7 from 6:00 – 7:00pm GMT during the Clinical Trials and Clinical Designs session. An abstract of the poster is available here.
“Regulatory guidance for interventional ALS trials encourages responder enrichment, however many current trials are designed with no or limited enrichment criteria,” commented Dr. Goyal. “The results of our comprehensive trial review suggest that additional efforts are needed to more fully integrate the concepts of disease heterogeneity and responder enrichment when designing interventional trials of ALS.”
“Brainstorm is committed to advancing the science of ALS clinical trial design and to ensure the highest quality data in the ongoing phase 3 ALS study,” said Ralph Kern M.D., MHSc, Brainstorm Chief Operating Officer and Chief Medical Officer. “We are proud to collaborate with Dr. Goyal and the study investigators in this important analysis of ALS clinical trial enrichment strategies.”
About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm’s website at www.brainstorm-cell.com.
Statements in this announcement other than historical data and information constitute “forward-looking statements” and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.’s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as “may”, “should”, “would”, “could”, “will”, “expect”, “likely”, “believe”, “plan”, “estimate”, “predict”, “potential”, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm’s limited operating history, history of losses; minimal working capital, dependence on its license to Ramot’s technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm’s forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
Media:Joseph PetrozielloBrainStorm Cell TherapeuticsPhone: +1.215.485.6797Email: JP@brainstorm-cell.com
Investors:Marcy Beth NanusSolebury TroutPhone: +1.646.378.2927Email: MNanus@troutgroup.com
BrainStorm Cell Therapeutics Inc.
Please visit their site for more information: Brainstorm Cell Therapeutics.com
All,Biotechnology,Healthcare News,Startup News